In an evolving biopharmaceutical industry, the need for advancements in biomanufacturing becomes critical. A trend toward the use of multi-product facilities requiring flexible manufacturing solutions, increasing competition from biosimilars, and increases in upstream expression levels have focused the need for manufacturing solutions that offer increased productivity and improved economics without sacrificing process robustness. The biopharmaceutical industry is addressing these challenges through various process intensification efforts, including unit operation optimization, linked processing, and continuous processing. To support these process intensification initiatives, we have taken a holistic approach to mAb processing in order to rationally design several technologies that enable both unit operation optimization and continuous processing. These technologies include multi-column continuous protein A chromatography, in-line low pH viral inactivation, and a fully-connected flow-through purification train. Experimental results with multiple mAbs, combined with processing modeling studies, will be presented to highlight the performance, economic, and facility-fit advantages of these technologies for both batch and continuous processing.

Downstream manufacturing technologies to enable process intensification

251st National Meeting (2016)

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